FDA is receiving “encouragement” from many directions right now to promote drug competition. Here’s what companies need to know.

The current political climate is an interesting one; FDA is receiving pressure from many angles, including the White House, Members of Congress – on both sides of the aisle – patient and other stakeholder groups, and industry, via the user fee agreements, to foster competition.

It’s also in the new FDA Commissioner’s DNA help advance competition. As a former venture capitalist, scientific advisor to companies, resident fellow at AEI and a cancer survivor, Gottlieb is strongly attuned to the benefits of a competitive marketplace.

Last week, I had the opportunity to present my perspectives on how FDA is promoting competition, during a webinar hosted by FDANews.

Here I provide a brief summary of the key regulatory and legislative vehicles that I see FDA using to promote competition; if you’re interested in further details, you can access the FDANews recording of the webinar, and/or see my full slide deck

“FDA Drug Competition Action Plan” to promote generic competition: This is a key piece of Gottlieb’s emerging agenda to drive competition. The plan includes several initiatives to promote generic competition, such as:

Publishing a list of drugs that are off-patent, with no generic competition

Drafting additional guidances for generic companies, in order to increase the first-cycle approval rate

Improving the regulatory process for “complex generics”

Committing to more frequent communication with generic applicants

Implementing REMS reforms, for example waiving the requirement that a brand and a generic develop a “shared REMS”

Rapid implementation of the the 21st Century Cures law: This is among Gottlieb’s key priorities. Some elements of Cures that I believe will help the agency advance a competitive marketplace include:

Establishing a framework for evaluating use of real-world evidence (RWE)

Reauthorizing all user fee agreements (UFAs): Over the past 25 years, PDUFA has been an important change agent in terms of streamlining FDA reviews and improving its interactions with industry.

FDA and industry have used the agreements to make improvements such as reducing the number of review cycles needed, improving communication with sponsors, and focusing resources on the most promising new therapies.

Each new PDUFA agreement has built on the success of the prior one.

Some of the elements of PDUFA VI that would encourage competition include the following, which also support the Cures law:

The generic drug (GDUFA) and biosimilar (BsUFA) agreements, which are only in their second round of negotiations, will provide greater resources to FDA overall and thus to help spur more efficient review and thus greater competition.

Notably, the legislative vehicle for the UFAs also includes some recently attached riders that are designed to promote generic competition (e.g., via a new “competitive generic therapies” pathway, based on the Breakthrough Therapy program for branded drugs, and by setting an 8-month deadline for review of generics when there are 3 or fewer generics on the market, or where the brand drug is on the drug shortage list).

The UFAs are currently in the legislative phase; they will become effective on Oct. 1, 2017, if they are passed by Congress and signed by the President before that date.

However, in practical terms, the UFAs must be passed and enacted before then – by July 2017 – in order to avoid triggering the need for FDA to begin sending out RIF (reduction in force) notices to employees whose positons are funded by user fees. Everyone involved wants to avoid this kind of hit to agency morale.

Next steps:

It comes as no surprise that a competition-focused agenda will thrive in a Republican Administration with a Republican-led House and Senate. Given the convergence of regulatory and legislative elements, there is a high likelihood that we will see advancement of initiatives around competition. Still, it’s important to keep in mind that when one company wins another may lose; thus, there may be nuances that may have specific impacts to some companies versus others. And as with all regulatory and legislative moves, the devil will be in the details, so it will be crucial to stay tuned as things unfold.

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